STD Testing in Outpatient Practices

NCT ID: NCT03246815

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6771 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-12
• Study Completion Date: 2020-12-30

Brief Summary

National guidelines have recommended routine STD screening (chlamydia and gonorrhea) for sexually active young women under the age of 25. Despite these recommendations, many young women are not being screened for STDs, with some estimates that less than 50% of women receiving health care are screened for chlamydia. Untreated STDs can lead to important sequelae to women's reproductive health including pelvic inflammatory disease, infertility and ectopic pregnancy. One of the most important barriers to widespread STD screening is provider failure to recognize an opportunity for STD screening. The goal of this study is to determine whether offering STD screening (chlamydia and gonorrhea) by a non-physician member of the medical practice (who receives an automated alert indicating STD screening should be offered) will be associated with a higher rate of STD screening in young women attending primary care practices compared to usual care (where a physician offers screening with no electronic alert). This study will be performed in UPMC-affiliated primary care practices (Family Practice, Internal Medicine, OB/GYN, Pediatrics). Practices will be assigned to the intervention or usual care. The intervention will be an auto-task in the electronic medical record to the non-physician/NP/PA medical staff (medical assistants, LPNs, RNs) to offer chlamydia and gonorrhea screening via urine or self-collected vaginal sampling, in an opt-out manner, to eligible women. Practices assigned to the usual care group will not have the intervention. STD screening rates (# women undergoing STD screening/# eligible women) will be compared between the to groups (intervention practices and control practices). Results of this study may be important to guide national STD screening recommendations and will address critical barriers to widespread STD screening.

Conditions

STD

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

universal opt-out screening for STDs

Patients who present to primary care practices who employee a universal opt-out strategy to medical assistants or nurses

No interventions assigned to this group

without universal opt-out screening for STDs

Patients who present to primary care practices who do not employee a universal opt-out strategy to medical assistants or nurses

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Women ages 15-24 Sexually Active Receiving care in one of the primary care offices affiliated with UPMC selected for this study.

Exclusion Criteria

Pregnancy

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CDC Foundation

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Harold Wiesenfeld

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harold C Wiesenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee-Womens Hospital of UPMC/associated community clinics

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO14110416

Identifier Type: -

Identifier Source: org_study_id